Hepatitis CCHIMENCT03876470
Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia
An observational study of Hepatitis C, run by University of Virginia.
Trial summary
The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Hepatitis C treatment as chosen by provider
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2019to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 300 subjects will be enrolled. Of these, 20 will be enrolled in the qualitative interviews and 4 will be enrolled in the ethnographic case studies.
Who may be able to join
- 18 years or older
- Detectable HCV viral load
- Attended a clinic appointment at one of our participating sites
Who cannot join
- Cognitive disability such that informed consent cannot be obtained
- Prisoners
- Unable to understand English
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Micro-elimination of Hepatitis C in a Rural Appalachian Community: The Implementation and Expansion of an Innovative Collaborative Care Model of Telehealth and Knowledge Sharing Focusing on People Who Inject Drugs
The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life.
Read the detailed description
The investigators will evaluate the proportion of patients at each step of the HCV care cascade before and after implementation of the collaborative care model. Additionally, participants will complete questionnaires at three time points: at the initiation of hepatitis C treatment, at treatment completion, and at the assessment of sustained virologic response. Questionnaires will assess quality of life, mental health, chronic liver disease outcomes, and substance use. A subset of participants will also complete semi-structured interviews at each of the three time points. Then, a smaller subset of participants will be selected for a detailed ethnographic case study focusing on treatment experiences, quality of life, forms of social support, and illness experience.
- Conditions
- Hepatitis C
- Being tested
- Hepatitis C treatment as chosen by provider
- Keywords
- Hepatitis C, Telehealth, Injection Drug Use
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis C treatment as chosen by providerOther
Participants' providers will determine the type of HCV treatment as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | All participants will receive HCV treatment as determined by their provider. HCV treatment is not assigned by the study. Receives: Other: Hepatitis C treatment as chosen by provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort-level Hepatitis C Treatment Progress
Change in the proportion of patients at each step of the HCV care continuum (linkage to care, treatment initiation, treatment completion and sustained virologic suppression) before and after program implemenation
Measured: 12 months
Secondary outcomes (4)
Patient Reported Quality-of-Life
Change in SF-12 scores from treatment initiation to treatment completion and sustained virologic response
Measured: 12 months
Depression
Change in Patient Health Questionnaire-2 (PHQ-2) scores from treatment initiation to treatment completion and sustained virologic response. Scale range: 0 to 6 with a higher score indicative of greater depressive symptoms.
Measured: 12 months
Health-Related Quality-of-Life
Change in Chronic Liver Disease Questionnaire: Hepatitis C version (CLDQ-HCV) scores from treatment initiation to treatment completion and sustained virologic response. Scores range from 1 to 7 with higher scores indicative of better quality of life. CLDQ-HCV includes a total score and 4 sub-scales (activity/energy, emotional, worry, and systemic), each scored from 1 to 7.
Measured: 12 months
Semi-Structured Qualitative Interview about Impact of HCV Treatment
Qualitative assessment of participants' experience with HCV treatment, including its impact on substance use behaviors, activities of daily living, social interactions, and mental and physical health
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start15 May 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Rebecca Dillingham, MD/MPH, University of Virginia
- Investigators
- Rebecca Dillingham, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876470
- Sponsor's protocol ID
- 21167
- Acronym
- CHIME
- Status last verified
- Apr 2019
- First submitted
- 25 Feb 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-elimination of Hepatitis C in a Rural Appalachian Community: The Implementation and Expansion of an Innovative Collaborative Care Model of Telehealth and Knowledge Sharing Focusing on People Who Inject Drugs
- ClinicalTrials.gov ID
- NCT03876470
- Acronym / sponsor ID
- CHIME / 21167
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Telehealth, Injection Drug Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 15 May 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life.
Detailed description
The investigators will evaluate the proportion of patients at each step of the HCV care cascade before and after implementation of the collaborative care model. Additionally, participants will complete questionnaires at three time points: at the initiation of hepatitis C treatment, at treatment completion, and at the assessment of sustained virologic response. Questionnaires will assess quality of life, mental health, chronic liver disease outcomes, and substance use. A subset of participants will also complete semi-structured interviews at each of the three time points. Then, a smaller subset of participants will be selected for a detailed ethnographic case study focusing on treatment experiences, quality of life, forms of social support, and illness experience.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: Hepatitis C treatment as chosen by providerAll participants will receive HCV treatment as determined by their provider. HCV treatment is not assigned by the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 300 subjects will be enrolled. Of these, 20 will be enrolled in the qualitative interviews and 4 will be enrolled in the ethnographic case studies.
Key inclusion criteria (3 listed)
- 18 years or older
- Detectable HCV viral load
- Attended a clinic appointment at one of our participating sites
Key exclusion criteria (3 listed)
- Cognitive disability such that informed consent cannot be obtained
- Prisoners
- Unable to understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis C treatment as chosen by providerParticipants' providers will determine the type of HCV treatment as appropriate. | Other | All Participants |
Primary outcome
Cohort-level Hepatitis C Treatment Progress
Time frame: 12 months
Change in the proportion of patients at each step of the HCV care continuum (linkage to care, treatment initiation, treatment completion and sustained virologic suppression) before and after program implemenation
4 secondary outcomes
Patient Reported Quality-of-Life
Time frame: 12 months
Depression
Time frame: 12 months
Health-Related Quality-of-Life
Time frame: 12 months
Semi-Structured Qualitative Interview about Impact of HCV Treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Dillingham, MD principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Dillingham, MD (4349820103, RD8V@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort-level Hepatitis C Treatment Progress (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.